KYPROLIS Drug Patent Profile
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When do Kyprolis patents expire, and when can generic versions of Kyprolis launch?
Kyprolis is a drug marketed by Onyx Pharms Amgen and is included in one NDA. There are eleven patents protecting this drug and three Paragraph IV challenges.
This drug has two hundred and twenty patent family members in forty-two countries.
The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Kyprolis
A generic version of KYPROLIS was approved as carfilzomib by DR REDDYS on September 9th, 2019.
Summary for KYPROLIS
| International Patents: | 220 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 94 |
| Patent Applications: | 3,371 |
| Drug Prices: | Drug price information for KYPROLIS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KYPROLIS |
| What excipients (inactive ingredients) are in KYPROLIS? | KYPROLIS excipients list |
| DailyMed Link: | KYPROLIS at DailyMed |
Recent Clinical Trials for KYPROLIS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GlaxoSmithKline | Phase 2 |
| Dong-A University Hospital | Phase 2 |
| Pfizer | Phase 1 |
Pharmacology for KYPROLIS
| Drug Class | Proteasome Inhibitor |
| Mechanism of Action | Proteasome Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for KYPROLIS
Paragraph IV (Patent) Challenges for KYPROLIS
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| KYPROLIS | For Injection | carfilzomib | 10 mg/vial | 202714 | 1 | 2018-11-28 |
| KYPROLIS | For Injection | carfilzomib | 30 mg/vial | 202714 | 1 | 2017-10-05 |
| KYPROLIS | For Injection | carfilzomib | 60 mg/vial | 202714 | 9 | 2016-07-20 |
US Patents and Regulatory Information for KYPROLIS
KYPROLIS is protected by twenty US patents and one FDA Regulatory Exclusivity.
Patents protecting KYPROLIS
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: KYPROLIS IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DARATUMUMAB PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY
Composition for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: KYPROLIS IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DARATUMUMAB PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: KYPROLIS IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: KYPROLIS IS INDICATED IN COMBINATION WITH DARATUMUMAB PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY
Compounds for enzyme inhibition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE IN COMBINATION WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY
FDA Regulatory Exclusivity protecting KYPROLIS
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY IN COMBINATION WITH DARATUMUMAB AND DEXAMETHASONE
Exclusivity Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Onyx Pharms Amgen | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Onyx Pharms Amgen | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-002 | Jun 3, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Onyx Pharms Amgen | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Onyx Pharms Amgen | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for KYPROLIS
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Amgen Europe B.V. | Kyprolis | carfilzomib | EMEA/H/C/003790 Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. |
Authorised | no | no | yes | 2015-11-19 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for KYPROLIS
When does loss-of-exclusivity occur for KYPROLIS?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 05243140
Estimated Expiration: ⤷ Try a Trial
Patent: 05243168
Estimated Expiration: ⤷ Try a Trial
Patent: 05313975
Estimated Expiration: ⤷ Try a Trial
Austria
Patent: 9109
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0510802
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 65407
Estimated Expiration: ⤷ Try a Trial
Patent: 66839
Estimated Expiration: ⤷ Try a Trial
Patent: 89921
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1014612
Estimated Expiration: ⤷ Try a Trial
Patent: 1180071
Estimated Expiration: ⤷ Try a Trial
Patent: 2847136
Estimated Expiration: ⤷ Try a Trial
Patent: 2875642
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 11489
Estimated Expiration: ⤷ Try a Trial
Patent: 14025
Estimated Expiration: ⤷ Try a Trial
Patent: 15605
Estimated Expiration: ⤷ Try a Trial
Patent: 17507
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 19353
Estimated Expiration: ⤷ Try a Trial
Patent: 30981
Estimated Expiration: ⤷ Try a Trial
Patent: 60835
Estimated Expiration: ⤷ Try a Trial
Patent: 61236
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 56079
Estimated Expiration: ⤷ Try a Trial
Patent: 58921
Estimated Expiration: ⤷ Try a Trial
Patent: 19353
Estimated Expiration: ⤷ Try a Trial
Patent: 30981
Estimated Expiration: ⤷ Try a Trial
Patent: 60835
Estimated Expiration: ⤷ Try a Trial
Patent: 61236
Estimated Expiration: ⤷ Try a Trial
Patent: 64834
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2005026556
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 07948
Estimated Expiration: ⤷ Try a Trial
Patent: 27618
Estimated Expiration: ⤷ Try a Trial
Patent: 51966
Estimated Expiration: ⤷ Try a Trial
Patent: 52047
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 27850
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 9020
Estimated Expiration: ⤷ Try a Trial
Patent: 3607
Estimated Expiration: ⤷ Try a Trial
Patent: 4776
Estimated Expiration: ⤷ Try a Trial
Patent: 6171
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 90155
Estimated Expiration: ⤷ Try a Trial
Patent: 08509
Estimated Expiration: ⤷ Try a Trial
Patent: 07537265
Estimated Expiration: ⤷ Try a Trial
Patent: 07538081
Estimated Expiration: ⤷ Try a Trial
Patent: 08522981
Estimated Expiration: ⤷ Try a Trial
Patent: 12121895
Estimated Expiration: ⤷ Try a Trial
Patent: 14141456
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 19353
Estimated Expiration: ⤷ Try a Trial
Patent: 30981
Estimated Expiration: ⤷ Try a Trial
Patent: 60835
Estimated Expiration: ⤷ Try a Trial
Patent: 61236
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 19353
Estimated Expiration: ⤷ Try a Trial
Patent: 30981
Estimated Expiration: ⤷ Try a Trial
Patent: 60835
Estimated Expiration: ⤷ Try a Trial
Patent: 61236
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 84585
Estimated Expiration: ⤷ Try a Trial
Patent: 06143664
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 5963
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 19353
Estimated Expiration: ⤷ Try a Trial
Patent: 30981
Estimated Expiration: ⤷ Try a Trial
Patent: 60835
Estimated Expiration: ⤷ Try a Trial
Patent: 61236
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1299821
Estimated Expiration: ⤷ Try a Trial
Patent: 070086924
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 60811
Estimated Expiration: ⤷ Try a Trial
Patent: 08216
Estimated Expiration: ⤷ Try a Trial
Patent: 10840
Estimated Expiration: ⤷ Try a Trial
Patent: 49763
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering KYPROLIS around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hong Kong | 1152716 | 用於抑制蛋白酶體的化合物 (COMPOUNDS FOR PROTEASOME ENZYME INHIBITION) | ⤷ Try a Trial |
| China | 102256616 | Combination therapy with peptide epoxyketones | ⤷ Try a Trial |
| South Korea | 101354280 | ⤷ Try a Trial | |
| Spain | 2360811 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KYPROLIS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1781688 | C01781688/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: SWISSMEDIC 65690 23.11.2015 |
| 1781688 | 132016000047656 | Italy | ⤷ Try a Trial | PRODUCT NAME: CARFILZOMIB OPZIONALMENTE IN FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE(KYPROLIS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1060, 20151123 |
| 1781688 | 12/2016 | Austria | ⤷ Try a Trial | PRODUCT NAME: CARFILZOMIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/15/1060 (MITTEILUNG) 20151123 |
| 1781688 | 300805 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: CARFILZOMIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1060 20151123 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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